Condition category
Injury, Occupational Diseases, Poisoning
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
11/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.abdn.ac.uk/hsru/hta/stars.shtml

Contact information

Type

Scientific

Primary contact

Mr John Keating

ORCID ID

Contact details

Department of Orthopaedics
University of Edinburgh
Royal Infirmary
Little France
Old Dalkeith Road
Edinburgh
EH16 4SU
United Kingdom
+44 (0)131 242 3436
johnkeating@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 94/24/03

Study information

Scientific title

Acronym

STARS

Study hypothesis

In a prospective randomised multicentre trial we will evaluate the management of displaced subcapital fractures in fit elderly patients with bipolar hemiarthroplasty, total hip arthroplasty or reduction and fixation. The trial will be conducted under the auspices of the Scottish Orthopaedic Trial Network, which involves the four university orthopaedic centres and associated district general hospitals. Patients will be randomised to one of three treatment groups and will be followed up for a minimum of two years.

Please note that, as of 11/05/2009, the anticipated end date has been updated from 31/08/2000 to 31/08/2002.

Ethics approval

Not provided at time of registration.

Study design

Prospective randomised multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Injury, occupational diseases, poisoning: Musculoskeletal injury

Intervention

There are three treatment options:
1. One method of mending the break is with a type of screw, sometimes with a plate on its side; the two parts of the bone are joined together, and no bone is replaced.
2. A second method using a hip replacement. The ball at the end of the femur bone is replaced by an artificial 'ball' which is fixed into the top of the rest of the femur bone; the socket is not replaced.
3. The third method is also a type of hip replacement. Like the second method, the ball of the femur is replaced, but the socket in the hip bone is also replaced.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Clinical outcome will include perioperative mortality and reoperation. Functional outcomes will be assessed using a hip rating questionnaire and the EuroQoL functional outcome questionnaire. A cost-effectiveness and cost utility analysis will be integrated into the study protocol.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/06/1996

Overall trial end date

31/08/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Elderly patients with bipolar hemiarthroplasty, total hip arthroplasty or reduction and fixation.

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

298

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/06/1996

Recruitment end date

31/08/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Orthopaedics
Edinburgh
EH16 4SU
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16202351

Publication citations

  1. Keating JF, Grant A, Masson M, Scott NW, Forbes JF, Displaced intracapsular hip fractures in fit, older people: a randomised comparison of reduction and fixation, bipolar hemiarthroplasty and total hip arthroplasty., Health Technol Assess, 2005, 9, 41, iii-iv, ix-x, 1-65.

Additional files

Editorial Notes